January 7, 2022

Angela Drysdale
VP, Regulatory Affairs
Abbott Diagnostics Scarborough, Inc.
10 Southgate Road
Scarborough, ME 04074

Re: EUA202537/S003
Trade/Device Name: BinaxNOW COVID-19 Ag Card
Dated: December 23, 2021
Received: January 3, 2022

Dear Ms. Drysdale:

This is to notify you that your request to update the shelf-life expiration date of the BinaxNOW COVID-19 Ag Card to
15 months at room temperature (28–30°C) based on the results of your ongoing stability studies. Upon review, we
concur that the data and information submitted in EUA202537/S003 supports the requested updates for use with
the BinaxNOW COVID-19 Ag Card. By submitting this EUA revision for review by the Food and Drug Administration
(FDA), you have complied with the Conditions of Authorization stated in the letter authorizing the emergency use of
the BinaxNOW COVID-19 Ag Card re-issued on December 16, 2020.

Sincerely yours,

Uwe Scherf -S
____________________________
Uwe Scherf, M.Sc., Ph.D.
Director, Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

U.S. Food & Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov